Friday, October 22, 2010

Since January of this year, ten Texas residents – all adults – have become infected with Listeria monocytogenes. Five of the 10 adults died; all five of the deaths occurred in people with serious underlying health conditions.

The Texas Department of State Health Services (DSHS) became aware of the possible outbreak during the summer, according to Press Officer Carrie Williams. Lab tests determined that the 10 cases were related; patient interviews and other epidemiological investigations pointed to chopped celery as a common source in six of the illnesses – including four of the deaths.

About a week or so ago, DSHS investigators identified the probable source of the celery as Sangar Produce & Processing Co., a San Antonio company. The probability became a certainty when the state lab recovered Listeria monocytogenes from a sealed package of chopped celery obtained directly from the Sangar facility. Additional testing confirmed that the Listeria recovered from the celery sample was a genetic match for the strain that infected at least six of the 10 outbreak victims.

Texas requested that Sangar suspend production to facilitate the state's investigation. The Company refused. So Texas ordered the plant to close – and ordered the recall of all outstanding production dating back to the beginning of January 2010.

The extent of the recall coincides with the duration of the outbreak; the first confirmed illness began in January 2010.

The scope of the recall is based on the sanitary violations observed by DSHS inspectors who visited the Sangar facility and were concerned that the contaminated celery may have spread Listeria monocytogenes to other items of produce. Specifically, the inspection revealed:

a condensation leak above a food product area,

soil on a preparation table, and

hand washing issues.

The investigation – including lab testing of environmental samples from the Sanger facility – is still in progress. The plant will remain closed until DSHS permits it to resume production.

According to Food Safety News, Sanger management disputed the Texas lab findings, saying that the state employed "... flawed collection methods, including improper attire, unrefrigerated transport of samples and a delay between collections and lab tests." Even if true, this would not negate a confirmed Listeria monocytogenes finding – especially a finding of the outbreak strain – in a sealedpackage of chopped celery procured at the production facility.

This outbreak investigation is a case study in why food safety regulators need mandatory recall authority. Had this been a multi-state outbreak investigation, the company's refusal to cooperate would have tied federal hands. Neither FDA nor USDA has the authority to require a food processor – even one operating under egregiously unsafe conditions – to shut down or to recall a product. All FDA can do (and has done on past occasions) is to issue a Consumer Alert. USDA is somewhat better equipped that FDA to apply pressure – it can withdraw its inspectors, and effectively shut down a food processing facility, but cannot mandate a recall.

While some people have expressed concern that mandatory recall authority would be wielded arbitrarily and excessively by regulators, that's not what happened in Texas. The Texas DSHS acted to protect the public health, according to Carrie Williams, only once it was "100% certain" that Sanger's chopped celery was the source of at least six cases of Listeria monocytogenes infections.

Associated Press reports that FDA is analyzing samples from Sangar, but that the results on samples taken October 15th are not yet complete. An independent lab also is testing samples on behalf of the company, which hopes that results from these analyses will contradict the Texas findings.

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